Abstract

Aim

Pembrolizumab (pembro) has shown efficacy in NSCLC, with improved outcomes in pts with greater tumor PD-L1 expression. KEYNOTE-010 (NCT01905657) compared the efficacy and safety of 2 pembro doses with those of docetaxel for PD-L1+ advanced NSCLC that progressed after ≥2 platinum-doublet chemotherapy cycles, with an appropriate tyrosine kinase inhibitor also required for pts with EGFR sensitizing mutations or ALK translocations.

Methods

Pts were stratified by ECOG PS (0 vs 1), region (East Asia vs non–East Asia), and PD-L1 expression level (tumor proportion score [TPS] ≥50% vs 1%-49%) and randomized 1:1:1 to pembro 2 or 10 mg/kg Q3W or docetaxel 75 mg/m2 Q3W. Treatment was continued up to 24 mo or until progression or intolerable toxicity. Response was assessed every 9 wk. Primary end points were OS and PFS (RECIST v1.1, central review) in the TPS ≥50% stratum and total population (ie, TPS ≥1%). ORR was a secondary end point. At final analysis, the study had ≥80% power to detect a 0.70 HR for OS in the total population (1-sided α = 0.825%).